GMP News, GMP guidelines, GMP Violations, GMP warnings A Public Health Global News Portal

Welcome to www.seekgmp.com FDA, WHO, EU, TGA, CDSCO guidelines...and GMP Violations news/warning letters..

150000+ Industry Leaders already read it everyday

Monday, January 23, 2017

The Top 5 Reasons Companies Ignore Root Cause Analysis by Christian Green at gmpviolations
















Anyone who works in manufacturing understands the importance of effective root cause analysis (RCA), but very few organizations invest appropriately in this skillset. There are a number of reasons, or rather excuses that we can identify that contribute to this situation
There always seems to be time to do the same job over and over
again, but no time to make sure it is done right the first time.


1.      “We just don’t have the time for RCA”
This is a common excuse in the manufacturing environment where fire fighting has become the normal way of doing things. Specialists spend their time running from one incident to the next, applying quick fixes to remove the symptoms before rushing on to the next problem.
In this environment, chances are that every member of the team is spending a good portion of the day addressing issues that could be eliminated if an underlying chronic condition within the infrastructure were resolved. There always seems to be time to do the same job over and over again, but no time to make sure it is done right the first time by eliminating the actual cause of the problem.
Statistics for repeat incidents build a compelling case for the time and cost savings of a good RCA capability within an organisation.

2.      The “Blame Culture”
It is inevitable that root cause analysis will uncover problems in your infrastructure that are the direct result of something incorrectly done—or not done—in the first instance. When there is a culture of finger pointing and blaming others, people may be reluctant to be involved in root cause analysis efforts for fear of being blamed for creating an error.
This can be avoided by concentrating on the process and not the people involved. It is also important to put ground rules in place to stop the process from turning into a witch-hunt. If people are concerned about being blamed, they are likely to withhold crucial information and slow down or even prevent the identification of the root cause.

3.      A Lack of Organizational Will
When complex problems are difficult to resolve, management commitment and support is required. This involves access to information, freeing up of resources, and having an open mind to solutions. Without management support for tackling big issues, the teams involved in root cause analysis will be pulled in other directions, are likely to become frustrated, and will, in all likelihood, not commit to the task of finding cause. Management must take the lead and assure team members of that they are committed to finding true cause.

4.      Lack of Skills, Knowledge and Experience in RCA
Effective root cause analysis requires a set of skills that may be lacking in the organization. Without a specific RCA skillset, a specialized team will struggle to find the root cause. It is likely to take longer, cost more, and be far less efficient than it would be if the appropriate training had been provided. Training and coaching in learning and applying RCA techniques removes this barrier and ensures that time spent in problem solving is effective and provides the results that are needed.

5.      Lack of Detail and Missing Data
When an organization is in fire-fighting mode, the information collected is often hurried and incomplete. It may be missing key facts that will aid in RCA. All too often, incident and problem data that is collected lacks the depth of information needed for a thorough assessment of the situation. When support teams jump to solutions without systematically collecting and analyzing the data, and if the selected solution eases the situation, little additional information will be collected. This leaves the problem-solving teams starting from scratch to investigate problems when many of the original details have been forgotten and never recorded. This makes RCA much more involved and difficult, bringing you back to the first point of not having enough time! It is a “chicken and egg” situation. Standardized collection of information by support staff will improve the success rate of your RCA initiatives.

An initial investment in training teams to use RCA, integrating the use of RCA processes, and removing some of the barriers to using RCA that are likely to exist in the organization, can pay big dividends in the long term. There will be some short-term pain in transitioning to effective root cause analysis as an integral part of an organization’s capability. However, the value of RCA will become evident as problems are efficiently and permanently resolved, and RCA becomes an integral part of operational activities.



Author: Christian Green
Critical Thinking Facilitator leading clients across industries to complex issue resolution:


www.gmpviolations.com
GMP News, GMP guidelines, GMP Violations, GMP warnings, GMP Trends. A Public Health Global News Portal (This story has not been edited by GMP Violations staff and is auto-generated from a syndicated feed.) Disclaimer: The Logos/Images posted here are belongs to respective to Authority / owners of firm.
Share:

0 comments:

Post a Comment

Related Posts Plugin for WordPress, Blogger...

Popular Posts

Related Posts Plugin for WordPress, Blogger...

Subscribe Free GMP Guidelines

Enter your email address:

Delivered by FeedBurner

Followers

Printfriendly

Subscribe via email for free

Services

Enter your email address:

Delivered by FeedBurner

Contact Form

Name

Email *

Message *

Menu :
Powered by Blogger.

Visitors

    Translater

    Category

    2016 (37) 2017 (85) 2018 (10) 211 CFR (2) 211.63 (1) 21cfr (1) 483 (5) AAFA (1) Abbott (2) AboutUs (1) ALCOA (1) Alerts (2) ANDA (1) Anshu (2) Antibiotics (1) apic (1) APR17 (8) APS (2) Articles (4) AstraZeneca (1) Aug17 (2) Aurobindo (2) Author (2) Authors (8) Biocon (1) cadila (1) capa (3) CDSCO (5) Change control (1) Christian Green (1) cipla (2) Cleaning validation (1) Data Integrity (9) dec16 (15) Definations (1) Deviations (1) Donald Trump’s (2) Downloads (17) Dr.Reddy's (4) eca (1) EIR (1) Eli Lilly (1) ema (12) EU (9) FDA (73) FDA Guide (20) FEB17 (15) Genaral (1) General Health (2) GMP (1) GMP News (36) gsk (2) GuidelineEU (10) GuidelinesG (5) GuidelineW (2) GV/0117/001 (1) GVAuthors (3) Health (4) HOSPIRA (1) ICH (3) ICHGuide (3) import alert (1) India (1) ISPE (1) James Bullock (1) JAN17 (23) Jul17 (8) July17 (1) Jun17 (4) Lupin (2) Mahender (40) MAR17 (13) Mar18 (7) May17 (10) May18 (1) MHRA (3) MHRA guide (1) Mumbai (1) Mylan (4) Natco (1) News (55) Non Complinaces (1) Nov16 (5) Novartis (1) oct (1) Oct16 (10) OCT17 (1) PDA (1) Personnel (1) pfizer (1) pics (8) Picsguide (2) QbD (1) Quality Docs (1) RCA (1) Recall (1) safety (1) Sanjeev Kumar Singh (4) Sanofi (1) Sep16 (6) Siegfried Schmitt (2) SUN (1) TGA (3) TOP 10 PHARMA (1) USP (2) Validation (3) Warning Letters (44) WHO (6) zika (1)

    Sponsors

    Theme Support